Data / Medical devices / United States / Anholt Technologies Inc.

Anholt Technologies Inc.: FDA-registered device maker in Avondale, PA, United States, 36 510(k) clearances

Name: Anholt Technologies Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Anholt Technologies Inc. is registered with the FDA (registration 2247992) in Avondale, PA, United States. It lists 19 device types. The FDA files 36 510(k) clearances under its listings, the newest dated March 31, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2247992
FEI number: 1000208827
Address: 440 Church Road, Avondale, PA, United States, 19311
Owner or operator: Medtec LLC (9033077)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
First device listed: January 28, 1994
Registered through: 2026
Brand names listed: ,, Access, AccuFix, AccuFix Tilting Radiotranslucent Headholder, AccuForm Cushion, AccuTatt; Accu-Tatt; ISO Mark; Opti-Tatt, AirDrive Caddie, Alta Multipurpose Device and more

Devices it lists

Device	Product code	Class	Role	Source
Accelerator, Linear, Medical	IYE	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Couch, Radiation Therapy, Powered	JAI	2	Manufacturer	accessdata.fda.gov
Device, Patient Transfer, Powered	FRZ	2	Manufacturer	accessdata.fda.gov
Holder, Head, Radiographic	IWY	1	Manufacturer	accessdata.fda.gov
Instrument, Quality-Assurance, Radiologic	LHO	1	Manufacturer	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Manufacturer	accessdata.fda.gov
Lift, Patient, Non-Ac-Powered	FSA	1	Manufacturer	accessdata.fda.gov
Marker, Skin	FZZ	1	Manufacturer	accessdata.fda.gov
Phantom, Anthropomorphic, Radiographic	IXG	1	Manufacturer	accessdata.fda.gov
Shield, Protective, Personnel	KPY	1	Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Manufacturer	accessdata.fda.gov
System, Radiation Therapy, Charged-Particle, Medical	LHN	2	Manufacturer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Manufacturer	accessdata.fda.gov
Table, Operating-Room, Electrical	GDC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Table, Radiographic, Stationary Top	IXQ	2	Manufacturer	accessdata.fda.gov
Table, Radiologic	KXJ	2	Manufacturer	accessdata.fda.gov
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	OUO	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 31, 2023	K230312	Iris AirShuttle	IYE	Substantially Equivalent	Qfix	accessdata.fda.gov
May 20, 2021	K211001	C-Qual M Breastboard; Monarch Overhead Arm Positioner	IYE	Substantially Equivalent	Medtec, Inc. Dba Civco Medical Solutions and Civco	accessdata.fda.gov
February 28, 2020	K193243	Alta Multipurpose Device	IYE	Substantially Equivalent	Qfix	accessdata.fda.gov
October 4, 2018	K182189	Encompass SRS Headframe ; Encompass MR SRS Headframe	IYE	Substantially Equivalent	Qfix	accessdata.fda.gov
September 7, 2018	K182079	Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask	IYE	Substantially Equivalent	Medtec Inc. Dba Civco Medical Solutions	accessdata.fda.gov
June 29, 2018	K180021	Proton Positioing and Immobilization Devices	IYE	Substantially Equivalent	Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap	accessdata.fda.gov
July 11, 2017	K171133	Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories	IYE	Substantially Equivalent	Qfix	accessdata.fda.gov
June 14, 2016	K160627	Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution	IYE	Substantially Equivalent	Qfix	accessdata.fda.gov
May 25, 2016	K153026	Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement	IYE	Substantially Equivalent	Medtec, Inc. D/B/A Civco Medical Solutions	accessdata.fda.gov
March 8, 2016	K153270	TruGuard Custom Tongue and Jaw Positioner	IYE	Substantially Equivalent	Bionix Development Corp.	accessdata.fda.gov
December 4, 2015	K152321	kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening	IYE	Substantially Equivalent	Qfix	accessdata.fda.gov
March 4, 2014	K132908	TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT	IYE	Substantially Equivalent	Medtec, Inc.	accessdata.fda.gov
September 26, 2013	K132084	PROTURA COUCH SOFTWARE	JAI	Substantially Equivalent	Med-Tec, Inc. D/B/A Civco Medical Solutions	accessdata.fda.gov
June 20, 2012	K120916	QFIX RADIOTHERAPY CHAIR	JAI	Substantially Equivalent	Wfr/Aquaplast Corp.	accessdata.fda.gov
June 8, 2012	K121545	BELLYBOARD, SBRT ACCESSORIES	LNH	Substantially Equivalent	Medtec Inc. Dba Civco Medical Solutions	accessdata.fda.gov
June 28, 2011	K111340	HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM	LNH	Substantially Equivalent	Medtec, Inc.	accessdata.fda.gov
May 14, 2010	K093738	MRI PATIENT POSITIONING DEVICES	LNH	Substantially Equivalent	Medtec, Inc.	accessdata.fda.gov
March 9, 2009	K090349	CLEARVUE PRONE BREAST TREATMENT TABLE	IYE	Substantially Equivalent	Orbital Therapy, LLC	accessdata.fda.gov
June 4, 2008	K080072	MRI PATIENT POSITIONING DEVICES	IYE	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.	accessdata.fda.gov
September 11, 2007	K071614	FIDUCIAL MARKERS	IYE	Substantially Equivalent	Civco	accessdata.fda.gov
May 4, 2006	K060671	KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS	JAI	Substantially Equivalent	Wfr/Aquaplast Corp.	accessdata.fda.gov
March 31, 2006	K060737	SINMED POSITIONING DEVICES	IYE	Substantially Equivalent	Sinmed BV	accessdata.fda.gov
April 9, 2004	K040773	PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM	IYE	Substantially Equivalent	Bionix Development Corp.	accessdata.fda.gov
September 2, 2003	K032156	ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT	IYE	Substantially Equivalent	Wfr/Aquaplast Corp.	accessdata.fda.gov
August 14, 2003	K031866	MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC	JAI	Substantially Equivalent	Med-Tec,Inc.	accessdata.fda.gov
December 23, 2002	K023293	MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02	IYE	Substantially Equivalent	Med-Tec,Inc.	accessdata.fda.gov
July 2, 2002	K021124	ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER	IYE	Substantially Equivalent	Wfr/Aquaplast Corp.	accessdata.fda.gov
October 26, 1998	K982624	MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242	IYE	Substantially Equivalent	Med-Tec,Inc.	accessdata.fda.gov
March 10, 1998	K974703	CARBON FIBER BREAST BOARD	IYE	Substantially Equivalent	Medtec, Inc.	accessdata.fda.gov
December 5, 1997	K973842	CARBON FIBER CONFORMAL COUCH TOP	IXQ	Substantially Equivalent	Medtec, Inc.	accessdata.fda.gov
July 6, 1995	K951808	MED-TEC REDI-FOAM	IYE	Substantially Equivalent	Medtec, Inc.	accessdata.fda.gov
May 30, 1995	K950866	HIP FIXATION SYSTEM	IYE	Substantially Equivalent	Medtec, Inc.	accessdata.fda.gov
July 18, 1994	K935411	MED-TEC, INC. BREAST BOARD, MT-250	IYE	Substantially Equivalent	Medtec, Inc.	accessdata.fda.gov
July 18, 1994	K935300	VAC-LOK IMMOBILIZATION SYSTEM	IYE	Substantially Equivalent	Medtec, Inc.	accessdata.fda.gov
July 18, 1994	K933227	UNI-FRAME HEAD IMMOBILIZATION SYSTEM	IYE	Substantially Equivalent	Medtec, Inc.	accessdata.fda.gov
May 26, 1994	K935067	AQUAPLAST	IYE	Substantially Equivalent	Wfr/Aquaplast Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 7, 2016	73543	Class II	Terminated	Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation t	Some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the zero reference with respect to other Access ClearVue Prone Breast devices. This can result in differences in scale orientation.	accessdata.fda.gov

Compare with other makers

Updated March 31, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.